| アブストラクト | BACKGROUND: Chimeric antigen receptor T-cell (CAR-T) therapy-related adverse events have become a focus of clinical attention. However, a comprehensive study of infection-related adverse events remains scarce, especially for high-risk, life-threatening infections. OBJECTIVE: To provide real-world evidence from a pharmacovigilance perspective for monitoring infection-related adverse events. STUDY DESIGN: This study investigated the characteristics of infection-related adverse events using the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. The disproportionality analysis was used to calculate the reporting odds ratios (RORs) of infections. Time to onset (TTO) and outcomes were analyzed to describe the temporal distribution and severity of infections. The least absolute shrinkage and selection operator (LASSO) regression was used to screen death-associated infections. The co-occurrence analysis was utilized to investigate the mechanism of infection occurrence. RESULTS: A total of 2142 reports of infection-related adverse events were obtained, accounting for 17.6% of total reports. At the high-level term (HLT) level, 31 positive safety signals were identified, including 12 bacterial infections, 12 viral infections, 4 fungal infections, 2 organ-specific infections, and 1 other infection. The median TTO of infections was 6 days (IQR: 2-24). The HLT-level positive signals with death proportions exceeding 50% predominantly pertained to sepsis-related infections, fungal infections, and Gram-negative bacterial infections. The LASSO analysis further demonstrated that those infections were associated with fatal outcomes. The co-occurrence analysis indicated that infections were associated with immune dysregulation. CONCLUSION: The prevalence, early onset, and broad spectrum of infection-related adverse events necessitate clinical attention. High-risk infections, including sepsis-related infections, fungal infections, and Gram-negative bacterial infections, especially warrant heightened vigilance. |
|---|
| ジャーナル名 | Transplantation and cellular therapy |
|---|
| Pubmed追加日 | 2026/3/28 |
|---|
| 投稿者 | Ding, Xiangyang; Ai, Kexin; Wu, Suwan; Wang, Hao; Zhang, Honghao; Li, Yuhua |
|---|
| 組織名 | Department of Hematology, Zhujiang Hospital, Southern Medical University,;Guangzhou, Guangdong Province, China.;Guangzhou, Guangdong Province, China.; Guangdong Engineering Research Center of;Precision Immune Cell Therapy Technology, Guangzhou, Guangdong Province, China..;Electronic address: liyuhua1974@outlook.com. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41895693/ |
|---|
